Laparoscopic Hartmann's reversal has better clinical outcomes compared to open surgery: An international multicenter cohort study involving 502 patients

Abstract Background Hartmann's procedure (HP) is used in surgical emergencies such as colonic perforation and colonic obstruction. “Temporary” colostomy performed during HP is not always reversed in part due to potential morbidity and mortality associated with reversal. There are several contributing factors for patients requiring a permanent colostomy following HP. Therefore, there is still some discussion about which technique to use. The aim of this study was to evaluate perioperative variables of patients undergoing Hartmann's reversal using a laparoscopic and open approach. Methods The multicenter retrospective cohort study was done between January 2009 and December 2019 at 14 institutions globally. Patients who underwent Hartmann's reversal laparoscopic (LS) and open (OS) approaches were evaluated and compared. Sociodemographic, preoperative, intraoperative variables, and surgical outcomes were analyzed. The main outcomes evaluated were 30‐day mortality, length of stay, complications, and postoperative outcomes. Results Five hundred and two patients (264 in the LS and 238 in the OS group) were included. The most prevalent sex was male in 53.7%, the most common indication was complicated diverticular disease in 69.9%, and 85% were American Society of Anesthesiologist (ASA) II‐III. Intraoperative complications were noted in 5.3% and 3.4% in the LS and OS groups, respectively. Small bowel injuries were the most common intraoperative injury in 8.3%, with a higher incidence in the OS group compared with the LS group (12.2% vs. 4.9%, p < 0.5). Inadvertent injuries were more common in the small bowel (3%) in the LS group. A total of 17.2% in the OS versus 13.3% in the LS group required intensive care unit (ICU) admission (p = 0.2). The most frequent postoperative complication was ileus (12.6% in OS vs. 9.8% in LS group, p = 0.4)). Reintervention was required mainly in the OS group (15.5% vs. 5.3% in LS group, p < 0.5); mortality rate was 1%. Conclusions Laparoscopic Hartmann's reversal is safe and feasible, associated with superior clinical outcomes compared with open surgery.


| INTRODUCTION
Hartmann's procedure (HP) may be performed for a myriad of colorectal diseases including large bowel perforation, obstruction, ischemic colitis, complicated diverticulitis, iatrogenic injuries, trauma, and cancer. [1][2][3][4][5] Reversal of Hartmann's colostomy is a technically demanding procedure with 50% morbidity and 10% mortality rates. 6 Moreover, 60% of patients will not undergo colostomy closure during the first postoperative year, 6,7 due to age, comorbidities, American Society of Anesthesiologists (ASA) score, or patient choice. 4,6 The laparoscopic approach to Hartmann's colostomy reversal (LS) was first described about 30 years ago. Over the last two decades, studies have evaluated the minimally invasive approach to Hartmann's colostomy reversal. Data suggest lower rates of morbidity and mortality compared with open surgery (OS). 1,2 However, evidence shows an average high conversion rate of 25% due to multiple dense adhesions and difficulty in identifying the rectal stump. [7][8][9] Recent evidence suggests that there are still gaps in the literature regarding analytical studies that have comparatively evaluated the outcomes of these two techniques. 10,11 It is necessary that the evidence be precise with respect to the usefulness and safety of each technique, since with the advance of technology and science, it is necessary to converge in the rational surgical practice, to save resources, reduce the risk of complications, guarantee functional capacity, and improve the quality of life. 12,13 Many studies report results from a single center. However, clinical and surgical outcomes need to be evaluated globally. 10,11 Therefore, the aim of this study was to compare OS and LS approaches for Hartmann colostomy reversal with emphasis on assessing clinical and surgical outcomes.

| Study design
The study has been reported in line with the strengthening the reporting of cohort studies in surgery answer criteria. 14

| Patient selection and data collection
Patients over 16 years of age who underwent a Hartmann's colostomy reversal procedure using either OS or LS were included.
Early postoperative follow-up within the first 30 days was undertaken by either outpatient clinic appointments or telephone interviews. Data from the participating surgeons at each of the 14 centers were collected and entered into a single database, maintained by the lead investigator. A table of standard definitions and operationalizations was created and shared with each participating institution.
Age, sex, body mass index (BMI), comorbidities, preoperative history of radiotherapy, and/or chemotherapy, American Society of Anesthesiologist (ASA) score, operative time, blood loss, time interval since HP, intraoperative findings, postoperative complications, ileus, intensive care unit (ICU) admission, length of hospital stay (LOS), reintervention, mortality, and other short-term results during the first 30 days after surgery were recorded.
All the patients underwent bowel preparation (including >1 enema to empty the rectal stump) approximately 24 h before surgery; preoperative broad-spectrum parenteral antibiotics were administered.

| Primary endpoints
The following primary endpoints were evaluated to determine any impact of the method of surgical intervention (OS vs. LS): 1. Postoperative complications and outcomes, including return to surgery and time to first bowel movement.
2. LOS, defined as the number of days from postoperative until discharge.
Primary endpoints were independently evaluated as binary outcomes. All associations of the surgical approach with an outcome were examined in univariable (unadjusted) and multivariable (adjusted) logistic regression analyses.

| Statistical analysis
Clinical findings or characteristics based on the surgical approach were assessed using a Student's t test and Mann-Whitney U test to compare the means between groups for normally distributed and nonnormally distributed data, respectively. The χ 2 test was used to compare proportions/frequencies between groups. Primary endpoints were evaluated independently as binary outcomes.
In the univariate analysis, a χ 2 test was used. Variables with a p ≤ 0.1 in the appropriate univariable model were selected for inclusion in the corresponding multivariable logistic or linear regression models. In the multivariate analysis, a stepwise logistic regression was used. Statistical significance was considered as

| Ethical statements
The study was approved by each of the institutions' ethics review boards. The protocol was implemented in accordance with the Declaration of Helsinki 16 and Good Clinical Practice guidelines. 17 The ethics committee exempted the collection of informed consent due to the retrospective nature of the study and the minimal risk.     Resumption of oral intake was faster in the LS versus the OS group in our study. Ileus was the most frequent postoperative complication and was more frequent in the OS group. It has been widely demonstrated that OS is associated with longer postoperative ileus and increased costs, due to a longer length of hospital stay. 21,22 Another factor for a rise in treatment costs is perioperative infection. 25,26 However, we were unable to identify any significant differences in SSI between the OS and LS groups in our study. We believe this finding was due to the fact that the most frequent site of SSI in both groups were at the stoma site.

| Mortality in OS versus LS
The main limitations of this study are that it is a retrospective, nonrandomized observational study without a standardized surgery protocol. These limitations may have led to selection bias. In an attempt to address this potential problem, we included a clear definition of the inclusion criteria and the resulting outcomes to ensure minimal bias inherent to this type of study. In addition, the number of cases per center was heterogeneous and may affect interpretation of the results. Nonetheless, to our knowledge, this study is the first cohort evaluation of these patients from different countries. This methodology potentially allows for extrapolation of the results to a worldwide population with a sufficient and significant sample size to determine the best surgical approach for Hartmann's reversal procedure.

| Conclusions
Laparoscopic Hartmann's reversal is a safe and feasible procedure associated with superior clinical outcomes compared with an OS approach. This minimally invasive approach has low morbidity and faster recovery. Based on these results, laparoscopy should be considered as the approach of choice for Hartmann's colostomy reversal procedure if appropriately skilled staff and surgeons are available.

AUTHOR CONTRIBUTIONS
All authors contributed to the conceptualization; data curation; formal analysis; investigation; methodology; validation; writingoriginal draft; writing-review & editing.

CONFLICT OF INTEREST
The authors declare no conflict of interest.

TRANSPARENCY STATEMENT
The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

DATA AVAILABILITY STATEMENT
The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. All authors have read and approved the final version of the manuscript.
The corresponding author had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis.

ETHICS STATEMENT
This study was approved by each of the institutions' ethics review boards. ORCID